Using remote ischemic conditioning to improve outcomes in acute ischemic stroke patients undergoing thrombectomy

Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke Treated With Mechanical Thrombectomy (RECAST-MT): A Multicenter, Randomized, Controlled, Open-label, Blinded Endpoint Trial

This study tests if a new treatment called remote ischemic conditioning can help stroke patients recover better after a procedure to remove a blood clot.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2105 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Capital Medical University (Academic / other)
• Locations: 56 sites (Suzhou, Anhui and 55 other locations)
• Trial ID: NCT06559241 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of remote ischemic conditioning (RIC) in patients with acute ischemic stroke caused by large vessel occlusion who are undergoing endovascular thrombectomy. The study aims to determine if RIC can provide neuroprotection and improve functional outcomes by reducing reperfusion injury. Participants will receive either a 14-day or 30-day RIC regimen alongside standard medical management and thrombectomy. The trial will assess the impact of RIC on patient recovery and survival rates post-stroke.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with acute ischemic stroke due to large vessel occlusion who are not suitable for intravenous thrombolytic therapy.

Not a fit: Patients with multiple vascular supply areas of cerebral infarction or those with contraindications to mechanical thrombectomy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance recovery and reduce mortality in stroke patients treated with thrombectomy.

How similar studies have performed: Previous studies have shown promise for remote ischemic conditioning in various ischemic conditions, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Age≥18 years；
2. Acute ischemic stroke due to large vessel occlusion in the anterior circulation that is not suitable for intravenous thrombolytic therapy, or has contraindications to intravenous thrombolytic therapy, or treated with intravenous thrombolytic therapy without recanalization;
3. Large vessel occlusion confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA), including the occlusion of the intracranial segment of the internal carotid artery (ICA) and M1 segment of the middle cerebral artery (MCA), is the cause of symptoms, and mechanical thrombectomy is planned within 24 hours from the time last known well;
4. Baseline score of the National Institutes of Health Stroke Scale (NIHSS) ≥ 6 points;
5. Patients or family members signed a written informed consent form.

Exclusion Criteria:

1. Imaging examination revealed the presence of multiple vascular supply areas of cerebral infarction (such as the simultaneous presence of infarction in both anterior and posterior circulation);
2. Absence of femoral artery pulsation, extremely difficult intravascular access, or extremely tortuous large vessels, which are expected to result in the inability to undergo timely endovascular treatment;
3. Difficult-to-control hypertension: continuous monitoring upon admission shows systolic blood pressure ≥180mmHg, or diastolic blood pressure ≥100mmHg;
4. Coma or lethargy patients (consciousness level score ≥2 in NIHSS);
5. Unable to obtain an accurate baseline NIHSS score;
6. Pre-stroke modified Rankin Scale (mRS) score \>1;
7. Baseline ASPECTS score ≤5;
8. Presence of bleeding tendency, deficiency of coagulation factors, or oral anticoagulant therapy with INR \> 3.0;
9. Baseline blood glucose \<2.7mmol/L or \>22.2mmol/L;
10. Baseline platelet count \< 30\*10\^9/L;
11. Severe known renal impairment defined as requiring dialysis (hemodialysis or peritoneal dialysis), or if known creatinine clearance rate \<30mL/min;
12. Cranial CT or MRI shows intracranial hemorrhage;
13. Cranial CT or MRI shows midline deviation and significant occupying effect;
14. Clinical history, previous imaging examinations, or clinical judgment suggesting intracranial tumors, arteriovenous malformations, or intracranial arterial dissection;
15. History of head injury in the past 3 months;
16. History of life-threatening allergy to contrast agents, nickel, titanium metal, or their alloys;
17. Pregnancy, if women of childbearing age have a positive urinary or serum β-human chorionic gonadotropin (β-hCG) test or are breastfeeding；
18. The life expectancy of patients is less than 6 months, and they cannot be evaluated within 3 months;
19. Limb deformity, soft tissue injury, or other conditions that affect the implementation of distant ischemia adaptation therapy;
20. Participating in other ongoing clinical trials;
21. Other conditions that the investigators believe are not suitable for participation in this study.

Where this trial is running

Suzhou, Anhui and 55 other locations

• Suzhou Municipal Hospital of Anhui Province — Suzhou, Anhui, China (Recruiting)
• Taihe County People's Hospital — Taihe Chengguanzhen, Anhui, China (Recruiting)
• Tongling People's Hospital — Tongling, Anhui, China (Recruiting)
• Beijing Luhe Hospital affiliated to Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Beijing Fangshan District First Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Fujian Provincial Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
• Zhangzhou Municipal Hospital of Fujian Province — Zhangzhou, Fujian, China (Recruiting)
• Shenzhen Second People's Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
• South China Hospital Affiliated to Shenzhen University — Shenzhen, Guangdong, China (Recruiting)
• The Second Nanning People's Hospital — Nanning, Guangxi, China (Recruiting)
• Cangzhou Central Hospital — Cangzhou, Hebei, China (Recruiting)
• Army Medical University Noncommissioned Officer School Affiliated Hospital — Shijiazhuang, Hebei, China (Recruiting)
• Hebei General Hospital — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• The Hongda Hospital of Jiamusi University — Jiamusi, Heilongjiang, China (Recruiting)
• Xunxian People's Hospital — Hebi, Henan, China (Recruiting)
• Jiaozuo Coal Industry Group Co., Ltd. Central Hospital — Jiaozuo, Henan, China (Recruiting)
• Luoyang Yanshi People's Hospital — Luoyang, Henan, China (Recruiting)
• Nanyang Central Hospital — Nanyang, Henan, China (Recruiting)
• Henan Province People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Xihua county people's hospital — Zhoukou, Henan, China (Recruiting)
• Huanggang Central hospital — Huanggang, Hubei, China (Recruiting)
• Huangshi central hospital — Huangshi, Hubei, China (Recruiting)
• Jingmen Central hospital — Jingmen, Hubei, China (Recruiting)
• Jingmen People's Hospital — Jingmen, Hubei, China (Recruiting)
• First People's Hospital of Tianmen — Tianmen, Hubei, China (Suspended)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
• The Third People's Hospital of Hubei Province — Wuhan, Hubei, China (Not_yet_recruiting)
• Yichang Central People's Hospital — Yichang, Hubei, China (Recruiting)
• the First People's Hospital of Changde — Changde, Hunan, China (Recruiting)
• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
• the First People's Hospital of Chenzhou — Chenzhou, Hunan, China (Not_yet_recruiting)
• The Central Hospital of Xiangtan — Xiangtan, Hunan, China (Not_yet_recruiting)
• Inner Mongolia Autonomous Region People's Hospital — Hohhot, Inner Mongolia, China (Not_yet_recruiting)
• The Fourth Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• Anshan Changda Hospital — Anshan, Liaoning, China (Recruiting)
• Dalian Central Hospital — Dalian, Liaoning, China (Not_yet_recruiting)
• The First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Recruiting)
• Shengli Oilfield Central Hospital — Dongying, Shandong, China (Recruiting)
• Jinan Third People's Hospital — Jinan, Shandong, China (Recruiting)
• Liaocheng People's Hospital — Liaocheng, Shandong, China (Recruiting)
• Liaocheng Third People's Hospital — Liaocheng, Shandong, China (Recruiting)
• The People's Hospital of Gaotang — Liaocheng, Shandong, China (Recruiting)
• Feixian People's Hospital — Linyi, Shandong, China (Suspended)
• Yeda Hospital — Yantai, Shandong, China (Recruiting)
• Mianyang third people's hospital — Mianyang, Sichuan, China (Recruiting)
• Ya 'an People's Hospital — Ya'an, Sichuan, China (Recruiting)
• The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
• Yueqing People's Hospital — Yueqing, Zhejiang, China (Recruiting)
• Beijing Chao-Yang Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Xunming Ji, MD, PhD

Conditions Acute Ischemic Stroke; Anterior Circulation Brain Infarction; Endovascular thrombectomy; Cerebroprotection; Remote ischemic conditioning